First approval for Daiichi Sankyo's Ezharmia

There was a tepid market reaction to news that Japan’s Daiichi Sankyo (TYO: 5468) had secured its first regulatory approval for Ezharmia (valemetostat tosilate), in a disease area where there is a severe lack of effective treatments. Having gained 1% initially, the stock closed more than 1.2% lower at 3,995 yen.

The company said this morning that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Ezharmia, a first-in-class dual inhibitor of EZH1 and EZH2, for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma (ATL).

Ezharmia previously received Orphan Drug Designation (ODD) from the MHLW for this indication and is now the first dual inhibitor of EZH1 and EZH2 to be cleared for the treatment of ATL. A rare and aggressive hematologic malignancy that can manifest as either leukemia or lymphoma, ATL occurs with higher frequency in certain regions of Japan and is associated with a five-year overall survival rate of around 14%.